By David L. Diehl, MD, FACPAcupuncture is a complementary and alternative medicine (CAM) modality that has undergone progressive acceptance by both patients and Western medical practitioners. Its major clinical application in the United States is for musculoskeletal conditions such as low-back pain, myofascial pain, headache, sciatica, and other similar conditions. Positive effects of acupuncture for digestive disorders have been known in Chinese medicine for centuries, but adoption of acupuncture for these conditions in Western medicine has lagged behind musculoskeletal indications. This may be due in part to a lack of convincing randomized data showing the efficacy of acupuncture for gastrointestinal (GI) conditions.

The functional digestive disorders, of which irritable bowel syndrome (IBS) is one of the most common, are a group of disorders of surprisingly high prevalence, whose adequate treatment continues to elude modern medicine. The functional disorders present a rich potential area of application for any CAM therapy. In patients attending GI clinics, those with IBS are most likely to see CAM practitioners.(1)

Mechanism of ActionThere is a plethora of information regarding the physiological basis of acupuncture effects on the digestive system. Extensive research using animal models, as well as data from human subjects, has shed light on how acupoint stimulation leads to changes in gastric acid secretion, GI motility, and hormone and neuropeptide metabolism. Regional or systemic autonomic nervous system changes also may contribute to these effects. A recent review examined the physiologic effects of acupuncture on the digestive tract.(2)

IBS is a multifactorial condition; contributions from diet, psychosocial factors, and underlying physiology all come together to shape an individual’s experience of pain or discomfort. Furthermore, any clinician with experience caring for patients with IBS knows that “there is IBS and there is IBS.” The heterogeneity of the diagnosis of IBS conspires to make clinical studies of this condition hard to do, and hard to interpret.

Common UsageAs relates to the GI tract, acupuncture is best known and most extensively studied for its effects on nausea. In a number of carefully designed and conducted trials, acupuncture has been shown to be useful for anti-emesis. Beyond the treatment of nausea, there is a paucity of controlled trials of acupuncture for any GI condition, although there is a long and distinguished history of acupuncture for GI symptoms in the Chinese medical literature dating back more than 2,000 years.

Special Considerations Concerning Acupuncture ResearchAcupuncture research, in comparison to pharmaceutical research, necessitates some special considerations. First, what is a proper control group to use? “Sham needling” (an invasive but “non-therapeutic” procedure such as shallow needling at non-acupuncture points) often is held to be the best, but also may dilute some of the effect of acupuncture due to non-specific effects of the minimal needling. “Placebo needling” involves non-penetrating simulation of needle placement (for example, taping a needle to the skin while the patient looks away). This obviously would require a subject naïve to previous acupuncture treatment. Blinding of the subjects and the investigators also is of great importance. Double blinding requires the use of a blinded evaluator who is not aware of allocation of the patient to the real or sham/placebo group.

There is much debate about which approach to point selection should be used for acupuncture studies as well. Some studies employ a “one-size-fits-all” approach, with all treated patients randomized to the active arm getting the same assortment of needles (which may range from one to 20 needles) applied to the same points. Other investigators insist that the treatment must be tailored to the individual patient and the presentation at that particular visit. Thus, the treatment may change from visit to visit. Some practitioners favor treatments three times a week (and occasionally more), while others may try to require visits no more frequently than once a week. Different schools of acupuncture theory and practice can alter specific point selection markedly, and this can lead to disagreement over the selection of the most efficacious treatment.

Finally, it must be understood that acupuncture is only a single part of an integrated health care treatment system that traditionally includes dietary manipulation, herbal medicine, massage (Tui Na), exercise modalities (such as Tai Qi), and breathing/meditation practice (Qi Gong). Evaluating acupuncture in isolation may lead to results that would be different than when several of these modalities are combined.

Clinical StudiesThere have been very few prospective randomized trials of acupuncture for IBS. All the studies that have been conducted have methodological failings, ranging from moderate to severe.

Lowe et al published (in abstract form) the results of a prospective randomized trial of real vs. sham acupuncture in a sample of 50 patients with IBS.(3) Treatments were given at nine points (specific acupoints were not specified in the abstract) twice weekly for four weeks. There was follow-up at four weeks and also at three months. The primary outcome was individual patient-determined treatment success rate; secondary outcome measures included McGill Pain Score and the IBS-36 (a validated IBS-specific quality-of-life tool).

There was no significant difference between patients’ perceptions of improvement (using 0-100% scale) in the two groups. Interestingly, both real and sham groups did show marked improvement compared to baseline in the McGill Pain Score as well as in the quality-of-life measurement. The authors concluded that acupuncture has no method-specific therapeutic benefit, but that participation in a trial can positively influence these measures.

Because this study was published only in abstract form, it is hard to assess certain specifics about methodology such as blinding. In addition, the study appears to be underpowered to detect an effect of real acupuncture.

Fireman et al performed a double-blind controlled study in a group of 25 patients.(4) Patients received two 30-minute sessions of real or control acupuncture, and then three weeks later were crossed over to receive the other treatment. The acupuncture treatment group was needled only at a single point, Large Intestine-4 (Li-4). Visual analog scales (VAS) were used to quantify response to either real or placebo needling. The authors found significant improvement in symptoms of alternating diarrhea and constipation, and overall feeling of well-being after the first needling session, but the change was not significant after the second session. There was no short- or long-term follow-up in this study.

This study contains a number of methodologic flaws and does not employ a sound research protocol for examining the effect of acupuncture on patients with IBS. First, only one point was used, and for only two sessions. It also is not clear whether the VAS was administered either immediately after the needling or at a later time. Despite the title of this study, it is not a reasonable evaluation of acupuncture treatment for IBS.

Chan et al performed a pilot study in which seven patients with IBS were offered a four-week course of acupuncture.(5) The patients filled out IBS symptom diaries on a daily basis for 28 days. The study used the same points on all patients. In all, eight acupoints were used, all stimulated bilaterally (for a total of 16 needles), and the needles were retained for only 3-5 seconds each. The authors found improvement in general sense of well-being and bloating, but no change in abdominal discomfort and bowel frequency. The obvious drawbacks to this study are small sample size, the absence of a control group and blinding, short follow-up, and the rather unusual needling technique involving “cookbook” selection of points and extremely short needle retention times.

In a description of a non-randomized clinical experience with IBS patients refractory to usual western therapy, Diehl et al offered acupuncture to a group of patients with functional dyspepsia (n = 14) and IBS (n = 10).(6) Initially, acupuncture was given weekly, and the interval between treatments was lengthened if possible. Outcomes were determined using patient and physician assessment of improvement and a quality-of-life survey. Length of follow-up was 2-14 months. In the 10-patient IBS group, three had a good response (almost complete or complete resolution of symptoms), six patients had a partial response (some improvement in symptoms or fewer recurrences of symptoms), while one patient had no response. The majority of patients experienced improvement in their symptoms, but ongoing therapy appeared to be necessary (at intervals of approximately 2-3 weeks) to maintain clinical improvement.

Adverse EffectsAcupuncture is a remarkably safe medical procedure. A long list of potential complications has been noted,(7) with transmission of viral infection and pneumothorax being among the most severe. Fainting, or so-called needle-shock, is perhaps the most common adverse effect, and can be seen in up to 2% of subjects. In two large recent studies of the safety of acupuncture, a total of 66,000 treatments by physicians or physiotherapists(8) or traditional acupuncturists(9) were evaluated prospectively. No fatalities were noted; significant adverse effects were seen in approximately 0.1% of patients in both studies. These results indicate that acupuncture is a very safe form of therapy.

Contraindications and PrecautionsIn some situations, IBS is a diagnosis of exclusion. Patients with atypical presentations, shorter duration of symptoms, or alarm symptoms of weight loss, rectal bleeding, or abnormal blood tests or GI radiology should be fully evaluated before the diagnosis of IBS can be made with certainty. In this way, a more serious underlying process will not be missed while CAM therapy is pursued.

ConclusionAt present, there are insufficient data to demonstrate that acupuncture is effective in the treatment of IBS, and the few studies that are available for review have significant methodological shortcomings.

RecommendationWhile we await funding for and completion of better-designed studies, there is little risk associated with acupuncture treatment for IBS, and individual patients may derive a benefit from this intervention.

Dr. Diehl is Associate Clinical Professor, New York University School of Medicine, and Director of Gastro- intestinal Endoscopy, Bellevue Hospital Center, in New York, NY.

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